|
Device | Gore Viatorr Tips Endoprosthesis and Gore Viatorr Tips Endoprosthesis with Controlled Expansion |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 |
PMA Number | P040027 |
Supplement Number | S077 |
Date Received | 01/03/2020 |
Decision Date | 01/29/2020 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Expansion of manufacturing to a newly constructed cleanroom within the same Phoenix facility. |